MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN; INTRAVASCULAR CATHETER

Catalog Number 38833514

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1131061.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-05-26.Medical device lot #: 1119917.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-05-13.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 2 angiocaths 22ga x 1,00in had a needle through the catheter.The following information was provided by the initial reporter: " the deviations are catheter folded and needle through catheter.".

Event Description

It was reported that 2 angiocaths 22ga x 1,00in had a needle through the catheter.The following information was provided by the initial reporter: " the deviations are catheter folded and needle through catheter.".

Manufacturer Narrative

H6: investigation summary.A physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1131061, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle had pierced through the catheter tubing causing the tubing to appear bent.Based off the provided photo the engineer was able to verify the reported defect.However, the device appeared to have been used indicating that the device was not received in this condition.If the needle had already pierced through the catheter tubing the needle would not have been able to thread the catheter into the patient's vein.Therefore, the failure was most likely not a manufacturing defect.

• Brand Name: ANGIOCATH 22GA X 1,00IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12601787
• MDR Text Key: 275873750
• Report Number: 9610048-2021-00135
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38833514
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1